The False Claims Act (FCA), which prohibits any person from knowingly causing the submission of false claims to the federal government for payment or approval, includes a qui tam provision that allows people who are not affiliated with the government to file actions on behalf of the government. Several states have also created FCA statutes with qui tam provisions. Recently, these acts have been used to bring claims against pharmaceutical companies for marketing drugs and medical devices for off-label uses—uses other than those specified on the product labels approved by the Food and Drug Administration (FDA). As a result, many pharmaceutical companies have paid staggering claims to settle these cases. For instance, Pfizer paid $430 million in 2004 to settle a claim that it encouraged physicians to prescribe the drug Neurontin, to treat bipolar disorder rather than epilepsy (its FDA approved use). As a result, Plaintiffs are increasingly alleging injury from off-label use of medical products in product liability suits against physicians and manufacturers. In the past, the learned intermediary doctrine has served as a powerful defense for manufacturers, but the application of this doctrine in off-label cases has been inconsistent among the states.
By way of background, the learned intermediary doctrine serves as a shield for manufacturers against consumer claims arising from allegations of failure to warn of a product’s risks. Essentially, the doctrine protects manufacturers from liability if they warn physicians of the risks associated with a drug or device. However, physicians commonly engage in off-label use, and it is impossible for manufacturers to warn physicians of every risk associated with all uses of a medical product.
The law regarding the learned intermediary doctrine and off-label use is conflicting. This creates difficulty in determining the best way to defend drug manufacturers in cases involving off-label use. In some jurisdictions, whether the learned intermediary doctrine applies depends on the manufacturer’s knowledge or the foreseeability of the off-label use. In other jurisdictions, the learned intermediary doctrine’s application depends on the manufacturer’s promotion of an off-label use. Still, in other jurisdictions, courts have assumed that manufacturers always have a duty to warn and have not applied the doctrine in the absence of warnings. Finally, some jurisdictions find that the learned intermediary doctrine applies in all cases because physicians use their entire knowledge base and training to determine what is best for the patient.
Given these varied approaches, litigators must look to their state law on the learned intermediary doctrine, specifically involving off-label use, in order to determine the relevant evidence and the likelihood that the learned intermediary doctrine will protect manufacturers sued in that particular jurisdiction.